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混合以限制ECMO中的氧气:一个排列控制的注册表 (BLENDER) 试验:研究协议和统计分析计划
Aidan Burrell1,2, Sze Ng1, Kelly Ottosen1
1Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
该BLENDER试验调查了静脉外体膜氧化 (VA ECMO) 患者的最佳氧和目标. 这项随机试验旨在确定保守或自由的氧化策略是否可以改善重症监护室 (ICU) 免费日.
科学领域:
- 关键护理医学 关键护理医学
- 心血管研究研究心血管研究
- 呼吸系统生理学 呼吸系统生理学
背景情况:
- 静脉外体膜氧化 (VA ECMO) 患者面临动脉高氧和缺氧的风险.
- 优化氧和是改善危急病患者治疗结果的关键.
研究的目的:
- 描述ECMO (BLENDER) 试验中混合物限制氧气的协议和统计分析计划.
- 在VA ECMO患者中比较保守与自由的氧化策略.
主要方法:
- 一个务实的,多中心的,注册表嵌入式,随机的临床试验.
- 在澳大利亚国家ECMO注册处注册VA ECMO治疗心脏性休克或心脏骤停的患者.
- 将保守的 (92-96% SpO2) 与自由的 (97-100% SpO2) 氧化策略进行比较.
主要成果:
- 主要结局:在第60天没有进入重症监护室 (ICU) 的日子.
- 二次结果:机械通风的持续时间,死亡率,缺氧期,神经认知结果和健康经济学.
- 300名患者的样本大小,以检测无ICU日的3天差异.
结论:
- 详细介绍了BLENDER试验协议和统计分析计划.
- 这项研究将提供关于VA ECMO中氧化策略的关键数据.
- 这些发现将指导临床实践,用于在重症患者中管理氧化.
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